antibody persistence in healthy children after primary and booster dtap-ipv-hep b-prp-t vaccine or control vaccine

Conditions: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis

Summary: the purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (dtap-ipv-hep b-prp-t) given in study a3l15 (nct 00362336). primary objective: to describe the antibody long term persistence at 3.5 and 4.5 years of age following a 3 dose primary series vaccination of either dtap-ipv-hep b-prp-t or combact-hib™ + oral poliovirus vaccine (opv) + engerix™ b vaccination at 6, 10 and 14 weeks of age and a booster vaccination of dtap-ipv-hep b-prp-t or combact-hib™ + opv at 15-18 months

all participants must have received the primary series of vaccinations and a booster vaccination in study a3l15 (nct 00362336). participants will receive no vaccination in this study but will undergo immunologic assessments at 3.5 and 4.5 years of age.

Eligibility criteria:
inclusion criteria : * aged 3 years and a half on the day of inclusion (42 months ± 60 days) * informed consent form signed by a parent or other legally acceptable representative and by an independent witness if the parent or other legal guardian is illiterate. * subject and parent/ legally acceptable representative able to attend the scheduled visits and to comply with all trial procedures. * receipt of primary vaccination with 3 doses of either dtap-ipv-hep b-prp-t or combact-hib™ + oral poliovirus vaccine (opv) + engerix™ b and a booster dose of either dtap-ipv-hep b-prp-t or combact-hib™+ opv. exclusion criteria : * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial. * incomplete primary and booster immunization at trial a3l15. * previous confirmed clinical, serological, or microbiological diagnosis of diphtheria, tetanus, whooping cough, poliomyelitis, haemophilus influenza b or hepatitis b after completion of a3l15 study. * subjects known to have received diphtheria, tetanus, pertussis, haemophilus influenza b and hepatitis b vaccination after completion of a3l15 study. * any vaccination within 30 days preceding inclusion, except for measles or poliovirus (monovalent) containing vaccines and pandemic influenza vaccines including pandemic h1n1-2009 strain, which may be received at least two weeks before the subject's blood sample collection * blood or blood-derived products received at the latest 3 months before inclusion, receipts of immunosuppressant drugs within the previous 3 months. * known or suspected congenital or acquired immunodeficiency since completion of a3l15 study. * serious chronic illness occurring after receipt of the primary and booster series (e.g. leukemia, lymphoma \[tor b cells\], crohn's disease). * known or suspected subject seroconversion for human immunodeficiency virus (hiv) or hepatitis c seropositivity since completion of a3l15 study. * febrile (temperature ≥ 38.0°c) or acute, moderate or severe systemic illness on the day of inclusion.

Keywords: diphtheria tetanus whooping cough hepatitis b poliomyelitis diphtheria-tetanus-acellular pertussis vaccines